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    In January 2003 The Cleveland Plain Dealer ran this headline – “Ohio lost 200,000 manufacturing jobs”. They blamed competition from India and China.

    In a recent article, Business Week discussed how Call Centers are being sent off shore, sending 10s of thousands of jobs overseas. Dell, Citigroup, Microsoft, General Electric an
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    d others major corporations now have oversea call centers.

    Microsoft and GE have one of the world’s most productive research and development centers in India

    Companies such are Ford, GM and Mercedes have built or off-shored entire plants to China.

    Tata India has one of the world’s largest and highly trained programming staf
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    s.

    Accountants are next to feel the heat from off shore competition. A clerk in the accountant’s office can scan a company’s financial data to an Internet server. An accountant in India will access this information over a secure link and process the financials overnight. The results are waiting at the accountant desk when he
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    comes in the next morning.

    How do you fight this?

    Outsourcing and off-shoring are here to stay.

    Outsourcing is defined as taking a specific task and having another company perform this service and then reintegrating the results back into the original company.

    Off-shoring is taking an entire plant and moving it to another c
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    untry.

    In the following example Boeing is building a new plane. Boeing has Russian designers designing the wings. Boeing also outsourced the electronics of this plane to a Japanese company. This Japanese company out sourced certain electronic components to the same company in Russia that Boeing is outsourcing the wing design
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    to.

    Boeing can employ five engineers in Russia for the price of one engineer in the United States.

    Are you untouchable?

    Let me define untouchable. Being untouchable is the ongoing learning process that a person must go through to move to the next level of professional and personal development.

    For example, in his book the
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    orld is Flat by Thomas Friedman, he discusses the outsourcing impact on his friend Bill Greer.

    Bill is 48 years old and he has 26 years experience as a free lance artist and graphics designer. His clients include such notable names as New York Times and McDonalds.

    In the past a client requests a finished piece of art. Greer
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    would sketch it, color it, mount it on illustration board, cover it with tissue, package it, and have it delivered. The process I just describes is known as the creation of camera ready art

    In the new process Greer’s client would requests a design, Greer would create the product using digital software and email the product ba
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    k to the client.

    Programs like Quark Express turned graphic design into a commodity. Software gives everyone the same tools and allowed almost anyone the ability to create acceptable art work. I use a program call GIMP and it is free.

    Greer pushed himself up the knowledge ladder and retooled his skill sets. He became the ide
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    a man. He would create the idea, draw it out and email it to his clients and they would finish it. For Greer, the old process was eight steps. The new process is three steps.

    This concept of creating ideas moved him into a whole new business. No longer just another friggin artist, his clients now buy his ideas.

    Bill Greer is
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    an untouchable. He is adaptable. He continues to retool his skills. He creates new forms of value for his clients.

    What are you doing to be an untouchable?

    We have been though this before. It happened when we moved from the agricultural age to the industrial age to the electronic age. On the farm you could get by with a thir
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    grade education and no one cared. During the industrial age you needed a high school diploma. Hundreds of thousands of people migrated from farms to cities during the industrial revolution and retooled their skills to find work.

    In the 1950’s, in Akron Ohio, rubber companies would rent buses and send them into the mountains
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    of Pennsylvania and West Virginia to bring worker to Akron to work in the Rubber factories. That’s how I came to live in Akron. My father left the coal mines of Pennsylvania to find a better life here. Little did he know that working in the rubber factory was no different that working in a coal mine.

    People who left the farm
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    adapted, learned new skills and became untouchable in their generation. Men who left the mountains and came to Akron to find employment learned new skills as well.

    In both of these cases education played a key role in this transformation.

    In the technology age America is being pushed by two very motivated competitors: India
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    and China. After years of repression they now see that they can have what Americans have enjoyed for so many years.

    Our grandparents came from the old country to create a better life.

    Our parents learned new skills and found ways to compete in their generation.

    Technology allows India and China to do the same thing; all wi
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    hout leaving home.

    What is America doing to compete? More importantly – what are you doing to do to compete – to become an untouchable? As I see it there are three things we must do:

    1. Stop being complacent and waiting for the government to do something. Government is about boundaries: political, commercial and geographical
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    . They don’t understand that with technology the world is flat and traditional boundaries cease to exist. Politicians are lawyers not engineers. They don’t understand technology.
    2. Take responsibility for your job situation. Treat your job as your business. You can’t change something unless you assume responsibility for
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    the results. Our parent and grandparents took responsibility when they left the farm or migrated to a new country.
    3. Finally, never stop learning. When you stop learning is when you die. Your death my not physical but it is an emotional and intellectual death all the same.

    As Satchel Page once said - don’t look back th
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    ey might be gaining on you.

    The untouchables never look back – they are always looking for the next way to provide greater value. If you are always providing value there is no need to look back.

    The best way to describe how to we should respond to outsourcing and off shoring is though this African Proverb:

    Every Morning in
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    frica, a gazelle wakes up
    It knows that is must out run the fastest lion or it will be killed
    Every morning the lion wakes up
    It knows it must out run the slowest gazelle or it will starve to death
    It does not matter if you are the lion or the gazelle,
    When the sun comes up
    You better start runnin


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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